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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: BDR who wrote (1415)	11/11/1998 2:49:00 PM
From: Thomas M.	Respond to of 10280

They did include this in one PR: "(S)-oxybutynin was well tolerated with only 14-16 percent of patients experiencing moderate-severe dry mouth." You're right, that more trials need to be done. I'm not sure what % experience dry mouth when taking the racemic drug. Tom

To: BDR who wrote (1415)	11/11/1998 3:14:00 PM
From: Biomaven	Read Replies (1) \| Respond to of 10280

Dale, It's always hard (and can be misleading) to compare results from different studies. Thus unless/until we get a head-to-head Phase III, it's hard to tell how good the S-oxy results really were. Poking around on the net, it seems the efficacy results were generally in the same ballpark as those for the drugs presently on the market - oxy and tolterodine. Here's an extract of a typical abstract: After 12 weeks' treatment, the mean frequency of micturition decreased by 21% and 19.5% in those receiving tolterodine (n = 118) and oxybutynin (n = 118), respectively, and by 10.5% in those on placebo (n = 57). Among those with urge incontinence at baseline (75% of patients), the mean number of incontinent episodes decreased by 47%, 71% and 19%, respectively, in those receiving tolterodine, oxybutynin and placebo. Here's a Detrol mini-review: pharminfo.com extract: Three placebo controlled, 12-week efficacy studies were conducted by the sponsor. The average number of times the subjects urinated within a 24-hour period was significantly decreased in subjects taking tolterodine in two out of the three studies. In addition, the volume of urine voided was significantly increased in all three studies. The number of episodes of incontinence over a 24-hour period was decreased compared with control in all three studies, but the decrease was not statistically significant. A dose-ranging study published by Rentzhog et al (1998) found dose- related improvements in patients with overactive bladders treated with tolterodine, with only mild or moderate antimuscarinic effects. This study found the optimum dose of tolterodine was 1 to 2 mg daily. The efficacy and safety of tolterodine was compared with oxybutynin -- a currently-available treatment -- in four studies of patients with overactive bladders (Appell, 1997). A pooled analysis of these studies indicated that both tolterodine and oxybutynin significantly decreased incontinence episodes and increased the volume of urine voided compared with placebo. On the other hand, the efficacy results claimed by Alza for its proposed time-release oxy seemed much better, although the side-effect profile still was worse than (S)-oxy (although better than straight oxy). (One abstract I saw by way of contrast didn't see any significant efficacy improvement with a time-release version). It may also turn out that there's a subset of people for whom (S)-oxy works well, and given it's better side-effect profile this would certainly make it a viable drug, even when stacked up against the new Alza drug (even assuming the Alza claims are correct, that is). I also came across an abstract detailing adverse cognitive effects in old people given anti-cholinergic drugs like oxy; likely this would be true for the Alza drug as well, but not for SEPR's (S)-oxy. Bottom line here, as near as I can judge, is that (S)-oxy remains a promising drug, but it's too early to tell just how good it's going to be. There's probably room for some extra dose-tweaking, and a time-release version might also improve performance. (Oxy has a short half-life, and so I would assume (S)-oxy has too). Maybe SEPR has enough at this point to successfully partner it. Peter